The time is upon us. A COVID-19 vaccine will soon be made available to “protect you” from the scourge of SARS-CoV-2. What will you do, when it is offered? You owe it to yourself to be well informed about what this COVID vaccine is, what it does for you and to you, and your reasoning behind the decision to take or decline the shot.
As I have written about before: what vaccines are, what they do in the body, and their impact on health is a complex topic. Take all of those issues and apply an exponential to the complexity factor as you sit down to learn about the COVID-19 vaccines. To kick off the consideration: non-influenza viral respiratory tract infections are the most common illnesses in people and are estimated to cost more than $40 billion annually. What a goldmine it would be to offer a vaccine to protect against winter viruses! Yet it has never happened. Take your own deep dive into why that is, but here it will suffice to say that has never happened because it can’t — at least not by using the standard rules of vaccine development and licensing. But these “warp speed” vaccines are different and innovative, say the developers and health officials. Yes, they are, but those innovative technologies are not new — they just never have been developed into a marketable product — because, again, they can’t be as long as companies are held to the rules.
mRNA Vaccines Are New, But Not Unknown
There are currently no licensed mRNA vaccines in the United States. However, researchers have been studying and working with them for decades. Interest has grown in these vaccines because they can be developed in a laboratory using readily available materials. This means the process can be standardized and scaled up, making vaccine development faster than traditional methods of making vaccines.
mRNA vaccines have been studied before for flu, Zika, rabies, and cytomegalovirus (CMV). As soon as the necessary information about the virus that causes COVID-19 was available, scientists began designing the mRNA instructions for cells to build the unique spike protein into an mRNA vaccine.
The declarations of a global pandemic and a US public health emergency have changed all the rules. Specifically, all devices/diagnostics/therapeutics used to address this public health emergency are exempt from the rules of approval and liability for damages. That goldmine for revenue opportunity is now open for strip mining. Once the “new technology” vaccines can slip into use through Emergency Use Authorizations the possibilities are endless.
Future mRNA vaccine technology may allow for one vaccine to provide protection for multiple diseases, thus decreasing the number of shots needed for protection against common vaccine-preventable diseases.
It’s important to understand the differences between vaccines that are in current use vs. the proposed COVID vaccines. In general a vaccine puts a product into your body that circulates around the tissues until your immune system sees it and reacts. The new COVID vaccines act in a very different way: they introduce manufacturing instructions that have to be taken up inside your cells to then have your own cells manufacture the proteins that are sent out into the body to stimulate your immune system. In essence these vaccines contain artificial “viruses” that infect your body. See explanations and graphics below:
Paul Offit explains mRNA vaccines:
Dr.Seheult explains vaccine mechanics:
NYT describes similarities between viral and vaccine infection:
So what does the flexibility of Emergency Use Authorization allow for? First, proof of real-world effectiveness of a vaccine does not need to meet the usual standards. It has been determined that COVID-19 vaccines need to be 50% effective at preventing disease. But then what is the definition of that disease? The CDC tells us that a COVID-19 patient can have no symptoms with a positive PCR test, OR can be a person with two of the following symptoms — fever (measured or subjective)/chills/rigors/myalgia/headache/sore throat/nausea or vomiting/diarrhea/fatigue/congestion or runny nose — regardless of diagnostic testing.
As long as the vaccine prevents 50% of people from developing a positive test or having a running nose or a headache — that is an effective vaccine. A low bar indeed.
Beyond that there is NO requirement for evidence that the vaccine reduces disease transmission. Those issues together mean that you can be vaccinated and go on to contract the infection but have no symptoms, and then while having no symptoms be able to spread that infection to other people.
This is where it becomes important to read the fine print. Not only is the intended effect of the vaccine minimal, but the known negative effects of similar trial vaccines are significant:
One of the foremost concerns of vaccine experts is the risk hastily tested coronavirus shots may lead to a condition known as vaccine-induced enhanced respiratory disease, or ERD. When this occurs, weakened antibodies actually help viruses enter cells, exacerbating the condition vaccination was meant to prevent.
Distinguishing between COVID-19 and ERD would require identifying biomarkers, such as certain types of white blood cells that are associated with allergic response and proteins involved in immune signaling, said Paul Offit, director of the Vaccine Education Center at Children’s Hospital of Philadelphia, in an email.
Put into plain language — the FDA is concerned that the COVID-19 vaccine could cause people to have more severe illness after getting the shot. They are concerned enough about this that the EUA documents specifically direct manufacturers to monitor for this outcome.
Data from studies in animal models administered certain vaccine constructs against other coronaviruses (SARS-CoV and MERS-CoV) have raised concerns of a theoretical risk for COVID-19 vaccine-associated enhanced respiratory disease (ERD). In these studies, animal models were administered vaccine constructs against other coronaviruses and subsequently challenged with the respective wildtype virus. These studies have shown evidence of immunopathologic lung reactions characteristic of a Th-2 type hypersensitivity similar to ERD described in infants and animals that were administered formalin-inactivated respiratory syncytial virus (RSV) vaccine and that were subsequently challenged with RSV virus due to natural exposure or in the laboratory, respectively (Refs. 4–9). Vaccine candidates should be assessed in light of these studies…
Here’s the kicker, that really bad event would likely happen when a person has a second exposure to the virus or in children whose mothers received the vaccine.
Then there is the issue of vaccine mandates. When I was in the Army I was given a lot of vaccinations. Some of those were used under the provisions of Investigational New Drugs (IND). As a member of the Armed Forces I did not have a choice in the matter — acceptance of those vaccines was coerced. Unless you are a member of the military, are mentally unfit, or are incarcerated you cannot legally be forced to take a new EUA authorized COVID-19 vaccine — period.
FDA must ensure that recipients of the vaccine under an EUA are informed, to the extent practicable given the applicable circumstances, that FDA has authorized the emergency use of the vaccine, of the known and potential benefits and risks, the extent to which such benefits and risks are unknown, that they have the option to accept or refuse the vaccine
Lastly, the unintended effects of these vaccines will not be known for many years. There are immediate, delayed, and transgenerational effects that are normally watched for in a time period call phase IV monitoring.
Although the vaccine development process and FDA’s evaluation are rigorous and comprehensive, there is still a need for ongoing surveillance of vaccines after FDA-approval to identify uncommon adverse events or long-term complications that may occur, and sometimes to monitor effectiveness. In certain cases, the FDA may require the manufacturer to conduct post-marketing studies to further assess known or potential serious risks. (These studies are sometimes called Phase 4 of development).
Many factors of how these vaccines will be used under the EUA will bypass or corrupt proper phase IV monitoring.
My closing thought for you to consider is that a mad rush had taken place to address valid concerns along with overblown fears, regarding this viral illness that is called novel. While there is a lot yet to be learned about it, we have well established measures to protect against as well as minimize the impact of this infection. Rational use of vaccinations can be an element of those control measures. Vaccination is never the only tool to use –
recent studies show that flu vaccination reduces the risk of flu illness by between 40% and 60% among the overall population during seasons when most circulating flu viruses are well-matched to the flu vaccine
So make your decision wisely, and be thoughtful in taking responsibility for holding your health in your own hands.